Post Market Clinical Experience Study of Sientra 207 Breast Implants

Post Market Clinical Experience Study of the Sientra 207 High-Strength Cohesive Plus (HSC+) Breast Implants in Primary and Revision Augmentation Participants

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02905617

Enrollment

113

Registered

2016-09-19

Start date

2016-08-31

Completion date

2020-07-15

Last updated

2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Augmentation, Breast Revision-Augmentation

Keywords

Breast Augmentation, Breast Revision-Augmentation

Brief summary

A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants

Detailed description

This study is designed to prospectively collect surgeon and participant satisfaction with the Sientra 207 implants in primary and revision augmentation participants over a 12-month time frame.

Interventions

DEVICESientra 207 Silicone Gel Breast Implant

The Sientra 207 Silicone Gel Breast Implant is a textured, round device with high-strength cohesive plus (HSC+) silicone gel fill.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

22 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Is a candidate for primary or revision breast augmentation and is at least 22 years of age, 2. Agrees to Sientra study requirements and to comply with office follow-up visits at months 3, 6 and 12.

Exclusion criteria

1. Does not meet the Investigator's standard eligibility for breast augmentation or revision surgery 2. Surgeon is planning to use acellular dermal matrix (ADM) or surgical mesh and/or recommend postoperative massage.

Design outcomes

Primary

Measure	Time frame	Description
Investigator Overall Satisfaction Questionnaire	3 months	The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026